Dye management system including an administration set with an in-line burette

ABSTRACT

An apparatus wherein the primary dye container is connected to a secondary dye container with sufficient safeguards, including at least one-way check valve and at least one stopcock between the primary dye container and the secondary dye container, to assure a sterile barrier between the primary and secondary dye sources so that less than the total amount of sterile contrast media can be transferred from the primary dye container in an amount sufficient to perform a cardiac catheterization procedure.

BACKGROUND OF THE INVENTION

Cardiac catheterization is an invasive procedure which exposes eachpatient undergoing the procedure and the vasculature of that patient topotential contamination, making sterility a high priority. Because ofthe risks of cross-contamination, most items used during thecatheterization procedure are disposable. Indeed, certain items which itwould be desirable to preserve are disposed of in the interest ofmaintaining patient-to-patient sterility.

For example, non-ionic contrast media or dyes used in a cardiaccatheterization procedure are relatively expensive fluids, with coststypically exceeding $1.00 per milliliter (ml). In the current cath labenvironment, non-ionic dye media is supplied to the lab in 150 mlcontainers which is, for the material provided, a standard container.However, a typical catheterization procedure uses anywhere from 80 to120 mls. At the end of such procedure, the container of non-ioniccontrast media is discarded and 30 to 70 mls of contrast media is alsodiscarded with that container, resulting in a loss of 20 to 47 percentof the contents of that container.

In a major cath lab setting where dozens of such procedures areperformed every day, the use of non-ionic contrast media over a yearstime can amount to upwards of one million milliliters of fluid. Thus, anapparatus which could preserve the sterility and integrity of thenon-ionic contrast media stored in the container and eliminate wastecould produce significant savings in a cath lab. The foregoing examplewould envision annual savings of $200,000 to $470,000 in a singlesignificant cath lab situation.

Of course, simply saving non-ionic contrast media is not enough. Theassociated apparatus must maintain the sterile barrier between fluidcontainer and patient and maintain that sterile barrier from patient topatient as well.

SUMMARY OF THE INVENTION

Accordingly, the present invention envisions an apparatus wherein theprimary dye container, or primary non-ionic contrast media container, isconnected to a secondary dye container such as a metered burette, withsufficient safeguards including at least one one-way check valve and atleast one stop cock between the primary dye container and the secondarydye container to assure that a sterile barrier exists between theprimary dye container and the secondary dye container, so that fluid canbe transferred from the primary dye container in an amount sufficient toperform a cardiac catheterization procedure.

Typically, the minimum amount of non-ionic contrast media required toperform a single cardiac catheterization procedure is in the range of 80to 120 mls. Accordingly, the one-way check valve between the primary dyecontainer and the secondary dye container permits 80 to 120 mls. ofnon-ionic contrast media to be released into the secondary dye containerwhen the stop cock therebetween is opened. When the transfer of fluidbetween the primary fluid container and the secondary fluid container iscomplete, the stop cock is closed to cut off the fluid transfer and tosupport the maintenance of a sterile barrier between the primary dyecontainer and the secondary dye container. Should additional fluid berequired during the procedure, the stop cock can be reopened to releasethrough the one-way check valve an amount of fluid sufficient tocomplete the procedure while still maintaining the sterile barrierbetween the primary dye container and the secondary dye container.

During the cardiac catheterization procedure, fluid flow is from thesecondary dye container through a fluid line connected by a catheter tothe patient. Before the contrast fluid media is transferred from thesecondary dye container to the patient, air bubbles in the contrastmedia are removed by returning aerated fluid in the line to thesecondary dye container and venting the bubbles through a vent-to-airmember provided in the secondary dye container, thereby preventing airbubbles from being introduced into the blood stream of the patient. Thevent-to-air member prevents a partial vacuum in this retrograde movementapplication. The vent also discharges air entrapped in the fluid to theatmosphere, as well as replaces fluid with air as such fluid istransferred from the secondary fluid container to the patient.

Further, a sterile barrier is maintained during the cardiaccatheterization procedure between the primary dye container and thesecondary dye container by the one-way check valve therebetween and, oncompletion of the catheterization procedure, the secondary dye containercan be disconnected from the primary dye container enabling the primarydye container to be connected to a next secondary dye containerassociated with a second procedure and a second patient.

In an alternate embodiment a pair of vented spikes may each be connectedto a primary dye container with proper coupling means connecting theoutput of each of two primary dye containers to a single connector andthen into a single secondary dye container.

The proposed apparatus as described herein eliminates the substantialwaste of a relatively expensive non-ionic contrast media, but yetmaintains a sterile barrier between primary and secondary dye(containers) so as to preserve the integrity and the sterility of thecatheterization procedure for each patient undergoing the procedure.Further, the apparatus of the present invention enables the developmentand use of primary fluid container containers of various sizes andconfigurations to improve the versatility and the convenience of suchcontainers, as well as to further minimize waste in the catheterizationprocedure.

A BRIEF DESCRIPTION OF THE DRAWINGS

The above described apparatus will be better understood when thedrawings briefly described below are considered with the detaileddescription which follows.

FIG. 1 is a schematic diagram of the dye management system of thepresent invention showing a primary dye container, a secondary dyecontainer and the connecting apparatus therebetween to preserve thesterility of the connection therebetween;

FIG. 2 is a detailed drawing of a preferred embodiment of the systemdisplayed schematically in FIG. 1; and

FIG. 3 is an alternate embodiment of the system of FIG. 2 wherein eachof a pair of vented spikes may be connected to a respective primary dyecontainer, to be connected to the described tubing and then to a singlesecondary dye container.

DETAILED DESCRIPTION

The dye management system 10 of the present invention is best seen inFIG. 1 wherein the system 10 is shown in schematic form. The primary dyecontainer 12 comprises the original container for the non-ionic contrastmedia used in a catheterization procedure. The primary dye container 12is connected to a secondary dye container 16 by tubing 14. In thepreferred embodiment, the secondary dye container 16 is an in-linemetered burette. Provided in the connecting tubing 14 between primarydye source 12 and secondary dye container 16 is a one-way check valve 18and a stop cock 20. Also provided is a disconnect 22, such as a luerlock connector, between the stop cock 20 and the one-way check valve 18.The disconnect 22 enables separation of the secondary dye container 16from the primary dye container 12 without compromising the sterilebarrier created between the primary dye container 12 and the secondarydye container 16 by the one-way check valve 18. A slide clamp 23 isinterposed between the primary fluid container 12 and the disconnect 22.

Extending from the bottom of the burette 16 is a fluid line 24 which isconnected by a suitable luer lock fitting 25 to a fluid input port 26 ofa multi-port manifold 27. Syringe 28 is connected to a syringe port 29of the manifold 28. A throughport line 30 of the manifold 28 connectsthe syringe port 29 to a catheter port 31 disposed on the manifold 28opposite the syringe port 29. Catheter 32 connects to the port 31 at aproximal end thereof and to the patient (not shown) at a distal endthereof.

The fluid input port 26 and the syringe port 29 are then opened toenable the syringe 28 to retract and draw contrast media from theburette 16 into the syringe. Fluid line 24 can be debubbled bydepressing the syringe 28 with the fluid input port 26 and the syringeport 29 open to return air bubbles through the fluid line 24 and backinto the in-line burette 16. A vent 33 enables the burette 16 to ventair returned thereto via fluid line 24. Once the fluid line 24, themanifold 27 and the syringe 28 have been primed to remove all airtherefrom, the syringe is filled with sufficient contrast media (10-12mls) to conduct a first phase of the cardiac catheterization procedure.The vent 33 of secondary dye container 16 also enables the user toreplace the fluid being transferred from the in-line burette 16 to thepatient with air, thus to prevent a partial vacuum from occurring in thefluid line 14 between the primary dye container and the secondary dyecontainer. The cardiac catheterization procedure is multiple injectionprocedure, wherein the end position of the catheter in the patient'sheart is changed prior to each fluid injection of 10-12 ml, to enablemultiple pictures of various portions of the patient's cardio-vascularsystem during the cardiac catheterization procedure.

The preferred embodiment of the dye management system 10 of the presentinvention is shown in FIG. 2. In the preferred embodiment of FIG. 2 anadministration set 113 connects the primary dye container 112 to asecondary dye container, an in-line burette 126. Administration set 113has provided at a proximal end thereof a vented spike 114. In thepreferred embodiment primary dye container 112 comprises a standard 150milliliter (ml) container of non-ionic contrast media. In alternativeconfigurations permitted by the dye management system of the presentinvention, the standard 150 ml glass container can be replaced by a 100ml glass container, or by plastic bags containing the dye, such bagsranging in size from 100 to 200 mls or larger. Container sizes in excessof 150 mls particularly emphasize the advantages of the dye managementsystem of the present invention, since the present system not onlyeffects direct savings of dye in the cath lab, but also enables themanufacture to reduce packaging costs by enabling them to package andsell dye in the larger containers.

The primary dye container 112 has connected thereto the vented spike 114which connects a fluid line 116 to the primary dye container 112. Aone-way check valve 118 is connected at its proximal end to the fluidline 116 and connected to a second fixed tubing section 119 at a distalend thereof. An adjustable clamp 117, for example, a slide or rollerclamp, is provided on the fluid line 116 between the spike 114 and theone-way check valve 118.

The tubing section 119 includes at a first end a female luer lockconnector 120 bonded to the distal end of one-way check valve 118 and atan opposite end a male luer lock connector 121. A slide clamp 122 isreceived on the fixed tubing section 119. A third removable tubingsection 124 having respective female and male luer lock connectors 124a,124b at opposite ends is connected at one end to fixed tubing section119 and at an opposite end to a proximal end of a stop cock 125.

The stop cock 125 is connected to burette tubing 127 of the in-lineburette 126 at the proximal end thereof. The proximal end of burettetubing 127 includes a female luer lock connector 127a which is connectedto the distal end of the stop cock 125. The distal end of buretteconnector tubing 127 is fixedly connected to the burette 126 at buretteinput tube 128 in an upper wall 130 of the burette.

The in-line burette 126 is a cylindrical member having a top wall 130, abottom wall 131 and cylinder 132 therebetween, with metering indicia 129provided on the cylinder 132 to enable the user to easily measure theamount of non-ionic contrast media transferred from the primary fluidcontainer 112 through administration set 113 into the burette 126.

On the upper wall 130 of the burette 126 is also provided a vent-to-airmember 132 which includes a tubing section 132a and a filter element132b. Mounted on tubing section 132a is a slide clamp 134. An injectionport 135 is also provided on the upper wall 130 of the burette 126.

On the bottom wall 131 of the burette 126 is provided a central outletdefined by a short section of PC tubing 136 which is molded in place. Amale luer lock connector 136a, provided at the distal end of the tubing136 engages female connector 137 which extends from a proximal end ofburette distal tubing 138 which extends between the lower end of theburette 126 and a manifold 140.

Fluid line 138 carries on its distal end a male luer lock connector 139which is connected to a fluid input port 141 of a multi-port manifold140. The manifold 140 includes a syringe port 142, a through-put line143 and a catheter port 144. The manifold 140 also includes input ports145 and 146, which need not be discussed in detail here.

A manual syringe 147 is connected to the syringe port 142 at one end ofthrough-put line 143. A catheter 148 is connected to catheter port 144,which is at the opposite end of through-put line 143. Conventionalmanifold plumbing enables opening and closing of the above-describedmanifold ports in the sequence described in greater detail below.

An adjustable roller clamp 150 is provided on fluid line 138 betweenin-line burette 126 and the manifold 140.

In operation, the administration set 113 functions as follows.

To enable fluid flow from the primary dye container 112 to the secondarydye container or in line burette 126, a first adjustable roller clamp117 mounted on fluid line 116 is opened and the slide clamp 122 on thefixed tubing section 119 is also opened. Then the stop cock 125 isopened to admit fluid through the tubing section 116, the fixed tubingsection 119, the removable tubing section 124 and the burette tubing 127to admit the non-ionic contrast media into the burette 126. Fluid flowthrough the administration set 113 is continued until non-ionic contrastfluid media is transferred into the in-line burette 126 in an amountsufficient to conduct a cardiac catheterization procedure (80 to 120mls).

At this point, the adjustable clamp on tubing section 116 is closed toprevent further flow of fluid from the primary dye container 112 intothe in-line burette 126. Next the slide clamp 122 carried on the fixedtubing section 119 is closed and then the stop cock 125 is closed toprevent further non-ionic contrast media from being transferred from theprimary dye container 112 to the secondary dye container or in-lineburette 126. During the fluid transfer procedure, the user can readilymeasure the amount of fluid being transferred to the in-line burette 126through use of the metering indicia 129 provided on the in-line burette.

During the loading of the in-line burette from the primary fluidcontainer 112, vented spike 114 admits air to the primary fluidcontainer 112 to prevent a partial vacuum from occurring in the primaryfluid container by replacing fluid removed therefrom with air taken inthrough the vented spike 114. With clamps 117, 122 and the stop cock 125closed, no further fluid can be passed into the in-line burette 126 andthe system is ready to dispense the fluid from the burette to thecatheter 148 attached to the patient.

To pass fluid from the in-line burette 126 to the patient, theadjustable roller clamp 150, fluid input port 141, and rotator port 142are opened to enable fluid to travel from the in-line burette 126through set tubing 138 through fluid input port 141 and syringe port 142of manifold 140. Fluid is drawn from the in-line burette 126 byretracting the syringe 147 connected to the syringe port 142 of themanifold 140. Fluid flow is from the in-line burette 126 through tubing138 through the fluid input port 141 through syringe port 142 and intothe syringe 147.

Set tubing 138 is primed to enable removal of air from tubing 138 priorto fluid transfer from in-line burette 126 to the manifold 140. With thefluid input port 141, the syringe port 142 open, fluid can be returnedthrough set tubing 138 and into burette 126 by extending the syringe tothe closed position to return air-in-line to the burette 126 which ventssuch air through the vent-to-air member 132.

Once the fluid line 138, the manifold 140 and the syringe 147 have beenprimed to remove all air therefrom, the syringe is filled withsufficient contrast media (10-12 ml) to conduct a first phase of thecardiac catheterization procedure. The fluid input port 141 may beclosed to prevent further ingress of contrast media to the manifold 140.With the fluid input port 141 closed, through-put line 143 is openedthereby enabling fluid flow from the syringe 147, through the manifold140, through the catheter 148 and into the patient. The cardiaccatheterization procedure is a multiple injection procedure, wherein theend position of the catheter in the patient's heart is changed prior toeach fluid injection of 10-12 ml, to enable multiple pictures of variousportions of the patient's cardiovascular system during the cardiaccatheterization procedure. During the fluid transfer from the in-lineburette 126 to the catheter 148 connected to the patient, the slideclamp 134 is opened to enable the vent-to-air member 132 to admit air tothe in-line burette 126 while fluid is drawn therefrom to assure that nopartial vacuum is created either in the in-line burette or in the fluidline between the primary dye container and the secondary dye containerduring the period of fluid withdrawal.

The slide clamp 134 is also engaged if the catheterization procedure isinterrupted while contrast media remains in the burette to prevent fluidflow out of the burette 126 through the vent 132 during the interruptionin such procedure.

When the procedure is complete, slide clamp 122 is closed, and theburette assembly distal of fixed tubing section 119 is separated fromthe administration set 113. The separated assembly remains intact fordisposal and includes removable tubing section 124, stop cock 125,burette tubing 127, in-line burette 126, set tubing 138, the manifold140 and the syringe 147. A sterile vented cover 231 (see FIG. 3A) isthen placed over the male luer lock connector 121 of the fixed tubingsection 119 to maintain the sterility of the primary dye container 112until a second new sterile burette assembly which would include theremovable tubing section 124 and all associated disposable components asenumerated above can be attached thereto to enable the primary dyecontainer 112 to be used in a second procedure with another patient.

ALTERNATIVE EMBODIMENT

An alternative embodiment of the present invention is shown in FIG. 3,wherein a pair of primary fluid containers 212 each receive a ventedspike 214 of an administration set 213 provided at the proximal end oftubing 216. At the distal end of each tubing set 216 is provided femaleadapter 218, which connects each tubing set 216 to a one-way stop cock220 to which is fixedly connected to a tubing section 222 by means of amale luer lock connector 221.

At respective distal ends thereof, each tubing section 222 is receivedin the proximal end of a two way connector 224. Tubing section 225connects the distal end of the connector 224 to the proximal end of aone-way check valve 226. A female luer lock adapter 228 is received intothe distal end of the one-way check valve 226 to connect tubing section229 to the check valve 226 at one end.

A sterile vented cover 231, shown in greater detail in FIG. 3A, isconnected to male luer lock connector 231 to provide a sterile barrierfor administration set 213 prior to use. After the cover 231 is removed,male luer lock connector 230 is joined to female luer lock connector124a of removable tubing section 124 of an in-line burette 126 andrelated assembly as set forth above.

In all respects the connections to administration set 213 from theremovable tubing section 124 to the in-line burette 126 and thereafterto the patient are the same as the connections distal to tubing section119 shown in FIG. 2 and need not be discussed in detail here.

To deliver non-ionic contrast media or any other fluid to the patientwith the apparatus of FIG. 3, fluid flow from one of primary fluidcontainers 212 is initiated by opening one of the one-way stop cocks 220to admit fluid through respective lines 216 and 221, to the connector224. The one-way check valve 226 carries fluid through lines 225 and 229to the fluid line 124, stop cock 125, burette line 127 and into thein-line metered burette 126.

While the apparatus described herein constitutes a preferred embodimentof the invention, it is to be understood that the invention is notlimited to this precise apparatus and that changes may be made withoutdeparting from the scope of the invention, which is defined in theappended claims.

We claim:
 1. A fluid management system comprising:a primary fluidcontainer; a secondary fluid container; a sterile fluid disposed in saidprimary fluid container for transfer to said secondary fluid container;a fluid flow input line connecting said primary and secondary fluidcontainers; a fluid flow control member provided in the fluid flow inputline between said primary and secondary fluid containers to interruptfluid flow from said primary to said secondary fluid container; a oneway fluid flow control device disposed in the fluid flow input linebetween the primary fluid container and the fluid flow control member toprevent fluid return from the secondary fluid container to the primaryfluid container thereby providing a sterile barrier for the primaryfluid container: at least one external fluid flow control memberprovided on the fluid flow input line for controlling fluid flow throughthe one-way fluid flow control from the primary fluid container to thesecondary fluid container and operable to terminate fluid flow; adisconnect member in the fluid input line engageable with the one wayfluid flow control device thereby enabling the disconnection of theprimary fluid container from the secondary fluid container without lossof fluid; and a sterile cap engaging the disconnect to preserve thesterile barrier for the primary fluid container thus to permit the useof the single container of fluid held in the primary fluid container ina second procedure with another secondary fluid container, thus tominimize waste and to maintain sterility in the primary fluid container.2. A fluid management system of claim 1 wherein the external fluid flowcontrol means includes an adjustable fluid flow clamp interposed betweenthe primary fluid container and the one-way fluid flow control deviceand a slide clamp interposed between the one-way fluid flow controldevice and the secondary fluid container.
 3. The fluid management systemas claimed in claim 2 wherein the one-way flow control device comprisesa one-way check valve disposed in the fluid flow input line and a fixedtubing section rigidly mounted to the distal end of the one-way checkvalve, the rigidly mounted tubing section receiving the slide clampmounted thereon to close flow from the one-way check valve to thesecondary fluid container.
 4. A fluid management system as claimed inclaim 3 wherein a vented spike is provided at the proximal end of thefluid flow input line, the vented spike engaging the primary fluidcontainer to open a fluid flow path between the primary and secondaryfluid container.
 5. A fluid management system as claimed in claim 4wherein the fluid flow control member comprises a stop cock and aremovable tubing section having locking members at opposite ends, aproximal end of the removable tubing section connected to the distal endof the rigidly mounted tubing section and a distal end connected to aproximal end of the stop cock, the distal end of the stop cock connectedto the fluid input of the secondary fluid container.
 6. A fluidmanagement system as claimed in claim 5 wherein the secondary fluidcontainer is a metered burette, the burette having metering indiciathereon to control and measure the amount of fluid delivered from theprimary fluid container to the secondary fluid container.
 7. The fluidmanagement system of claim 6 wherein the metered burette of thesecondary fluid container is an in-line burette which includes a topwall, a bottom wall and a metered cylinder therebetween, with a fluidinput in the top wall and a fluid output in the bottom wall, the fluidoutput including a fluid infusion line extending from the bottom wall ofthe burette to the patient.
 8. A fluid management system as claimed inclaim 7 in which the fluid input in the top wall of the in-line burettecomprises a flexible tubing section passing through the top wall andbonded thereto at a distal end thereof and having a locking connectionto the stop cock of the fluid flow input line at a proximal end thereof.9. A fluid management system as claimed in claim 8 wherein a vent-to-airmember is provided in the top wall of the burette, the vent-to-airmember including a rigid connector on the top wall of the burette, aflexible tubing section extending from said rigid mounting member, anouter filter element, and a slide clamp engaging the flexible tubingsection of said vent-to-air member, to selectively open and close saidvent-to-air member.
 10. A fluid management system as claimed in claim 9wherein the fluid output of the in-line burette comprises a rigidconnector passing through and rigidly joined to the bottom wall of theburette, a section of flexible tubing extending from the fluid output ofthe burette to the patient, and a locking member provided at theproximal end of the flexible tubing section, the rigid connectorengaging the locking member to secure the flexible tubing section to therigid connector of the fluid output of the in-line burette.
 11. A fluidmanagement system as claimed in claim 10 wherein the fluid output fromthe burette to the patient includes a multi-port manifold comprisingmultiple interconnected ports, including a fluid input port, a syringeport and a catheter port, with a throughput line interconnected betweenthe respective ports, the flexible tubing extending from the fluidoutput of the burette and connected at a distal end thereof to the fluidinput port, a syringe engagable with the syringe port of the manifold,and a catheter connected to the catheter port whereby fluid can be drawninto the syringe from the fluid output of the burette and thereafterfluid is expelled from the syringe to the catheter port along the fluidthroughput line of the manifold and into the catheter connected to thepatient.
 12. A fluid management system comprising multiple primary fluidcontainers;a secondary fluid container; a sterile fluid disposed in saidprimary fluid containers for transfer to said secondary fluid container;respective primary fluid input lines connecting each of said primaryfluid containers to the secondary fluid container; a fluid flow controlmember provided in each of the primary fluid input lines between arespective primary fluid container and said secondary fluid container tointerrupt fluid flow from said primary to said secondary fluidcontainer; a connector connecting each of said primary fluid input linesto a secondary fluid container input line, to direct flow from each ofthe primary fluid containers to a single secondary fluid input line; aone-way fluid flow control device disposed in the secondary fluid flowinput line between the primary fluid containers and the secondary fluidcontainer to prevent fluid return from the secondary fluid container tothe primary fluid containers; at least one external fluid flow controlmember provided on the single secondary fluid input line for controllingfluid flow from the primary fluid containers to the secondary fluidcontainer; a disconnect member in the secondary fluid flow input line; afluid flow control member engageable with the disconnect member in thesecondary fluid flow input line, the one-way fluid flow control deviceproviding a sterile barrier for the primary fluid containers, theexternal fluid flow control member operable to terminate fluid flow toenable the disconnection of the secondary fluid container from theprimary fluid containers without loss of fluid; and a sterile capengaging the disconnect member to preserve the sterile barrier for theprimary fluid containers, thus to permit the use of the single source ofmedical fluid in said primary fluid containers in a second procedurewith another secondary fluid container, thus to minimize waste whilemaintaining sterility in the primary fluid containers.
 13. A fluidmanagement system as claimed in claim 12 wherein the primary fluid flowinput line connected to each of the primary fluid containers includes avented spike at a proximal end thereof to engage the primary fluidcontainers and to initiate flow between a respective primary fluidcontainer and the secondary fluid container;a fluid flow control membercomprising a stop cock mounted distally of the vented spike in eachprimary fluid flow input line; a multiple input/single output connectordisposed distally of the stop cock, and receiving at each input arespective primary fluid flow input line; a secondary fluid lineattached to the single output of the connector; a one-way fluid flowcontrol device comprising a one-way check valve fixedly mounted in thefluid line between the connector and the secondary fluid container, theproximal end of the one-way check valve receiving a flexible tubingsection fixedly mounted thereon, said flexible secondary fluid flowinput line carrying at its proximal end a connector; and a sterile capoverlying the connector to, following disconnection, preserve a sterilebarrier.
 14. A fluid management system as claimed in claim 13 wherein anexternal fluid flow control clamp engages the flexible tubing section ata location intermediate the fluid output of the burette and the patient,to control fluid flow therebetween.
 15. A fluid management system asclaimed in claim 14 wherein the secondary fluid container is a meteredburette, the burette having metering indicia thereon to control andmeasure the amount of fluid delivered from each of the primary fluidcontainers to the secondary fluid container.
 16. A fluid managementsystem as claimed in claim 15 wherein the metered burette of thesecondary fluid container is an in-line burette which includes an upperwall, a bottom wall and a metered cylinder therebetween, with a fluidinput in the top wall and a fluid output in the bottom wall, the fluidoutput including a fluid infusion line extending from the bottom wall ofthe burette to the patient.
 17. A method of transferring a sterile fluidfrom a primary fluid container to a secondary fluid container in a fluidmanagement system comprising at least one primary fluid container, asecondary fluid container, a sterile fluid disposed in said primaryfluid container for transfer to said secondary fluid container, and afluid input line connecting said primary and secondary fluid containersand maintaining a sterile barrier within said primary container before,and during and after fluid transfer, including disconnection of saidsecondary container therefrom, the method comprising:disposing a fluidflow control member in the fluid flow input line between said primaryand secondary fluid containers to interrupt fluid flow from said primaryto said secondary fluid container; disposing a one-way fluid flowcontrol device in the fluid flow input line between the primary fluidcontainer and the secondary fluid container to prevent fluid return fromthe secondary fluid container to the primary fluid container and toprovide a sterile barrier for said primary container; enabling thedisconnection of the primary fluid container from the secondary fluidcontainer; and capping the fluid input line connected to the primaryfluid container to maintain the sterile barrier for the primary fluidcontainer to permit the use of the sterile fluid in the primary fluidcontainer in a second procedure with another secondary fluid container,thus to minimize waste and to maintain sterility in the primary fluidcontainer.